Question 1

Who is the manufacturer of DYNAMETER 50 LB.?

Accepted Answer

Fred Sammons, Inc. filed the 510(k) submission for DYNAMETER 50 LB. (K772415).

Question 2

What is the FDA product code for DYNAMETER 50 LB.?

Accepted Answer

HRW. It is classified under 21 CFR 888.1250 as a Class 1 device in the Orthopedic panel.

Question 3

When was DYNAMETER 50 LB. cleared by the FDA?

Accepted Answer

Jan 5, 1978 (decision: SESE).

Question 4

What is the regulatory pathway for DYNAMETER 50 LB.?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like DYNAMETER 50 LB.?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K772415
Device Name	DYNAMETER 50 LB.
Applicant	Fred Sammons, Inc.
Product Code	HRW · Orthopedic
Decision Date	Jan 5, 1978
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1250
Device Class	Class 1

DYNAMETER 50 LB.

Device Facts

Regulatory Classification

Identification